Tekamlo

PATIENT INFORMATION

Tekamlo™
(tek'-am-lo)
(aliskiren and amlodipine) Tablets

Read the Patient Information that comes with Tekamlo
before you start taking it and each time you get a refill. There may be new
information. This information does not take the place of talking with your
doctor about your condition and treatment. If you have any questions about
Tekamlo, ask your doctor or pharmacist.

What is the most important information I should know
about Tekamlo?

Tekamlo can cause harm or death to an unborn baby.
Talk to your doctor about other ways to lower your blood pressure if you plan
to become pregnant. If you get pregnant while taking Tekamlo, tell your doctor
right away.

What is Tekamlo?

Tekamlo is a prescription medicine that may be used:

as the first medicine to lower your high blood pressure
if your doctor decides that you are likely to need more than one medicine.

to treat your high blood pressure when one medicine to
lower your high blood pressure has not worked well enough.

if you are already taking the medicines aliskiren and
amlodipine to treat your high blood pressure.

Your doctor may prescribe other medicines for you to take
along with Tekamlo to treat your high blood pressure.

It is not known if Tekamlo is safe and works in children
under 18 years of age.

Who should not take Tekamlo?

If you get pregnant, stop taking Tekamlo and call your
doctor right away. If you plan to become pregnant, talk to your doctor about
other treatment options for your high blood pressure.

If you have diabetes and are taking a kind of medicine
called an angiotensin-receptor-blocker or
angiotensin-converting-enzyme-inhibitor.

If you are allergic (hypersensitive) to aliskiren,
amlodipine or other dihydropyridines (calcium­channel blockers, a group of
medicines to lower blood pressure to which amlodipine belongs) or any of the
other ingredients of Tekamlo listed at the end of this leaflet.

What should I tell my doctor before taking Tekamlo?

Before taking Tekamlo, tell your doctor if you:

have kidney problems

have liver problems

have ever had an allergic reaction to another blood
pressure medicine. Symptoms may include: swelling of the face, lips, tongue,
throat, arms and legs, and trouble breathing.

suffer from heart disorders or if you experienced a heart
attack

have any other medical problems

are pregnant or planning to become pregnant. See “What
is the most important information I should know about Tekamlo?”

are breastfeeding. It is not known if Tekamlo passes into
your breast milk and if it can harm your baby. You and your doctor should
decide if you will take Tekamlo or breastfeed. You should not do both.

Tell your doctor about all the medicines you take including
prescription and nonprescription medicines, vitamins and herbal supplements.
Tekamlo and certain other medicines may affect each other and cause side
effects.

medicines used to treat AIDS or HIV infections (such as
ritonavir, indinavir)

Know your medicines. Keep a list of all your medicines.
Show this list to your doctor or pharmacist when you get a new medicine. Your
doctor or pharmacist will know what medicines are safe to take together.

How should I take Tekamlo?

Take Tekamlo exactly as prescribed by your doctor. It is
important to take Tekamlo every day to control your blood pressure.

Take Tekamlo one time a day, about the same time each
day.

Take Tekamlo the same way every day, either with or
without a meal.

Your doctor may change your dose of Tekamlo if needed. Do
not change the amount of Tekamlo you take without talking to your doctor.

If you miss a dose of Tekamlo, take it as soon as you
remember. If it is close to your next dose, do not take the missed dose. Just
take the next dose at your regular time.

If you take too much Tekamlo, call your doctor or a
Poison Control Center, or go to the nearest hospital emergency room.

What are the possible side effects of Tekamlo?

Tekamlo may cause serious side effects:

Harm to an unborn baby, causing injury or death. See
“What is the most important information I should know about Tekamlo?”

Severe Allergic Reactions and Angioedema.
Aliskiren, one of the medicines in Tekamlo, can cause difficulty breathing or
swallowing, tightness of the chest, hives, general rash, swelling, itching,
dizziness, vomiting, or abdominal pain (signs of a severe allergic reaction).
Aliskiren can also cause swelling of your face, lips, tongue, throat, arms and
legs, or the whole body (signs of angioedema). Get medical help right away and
tell your doctor if you get any one or more of these symptoms. Angioedema can
happen at any time while you are taking Tekamlo.

Low blood pressure (hypotension). Your blood
pressure may get too low if you also take water pills, are on a low-salt diet,
get dialysis treatments, have heart problems, or get sick with vomiting or
diarrhea. Lie down if you feel faint or get dizzy. Call your doctor right away.

Possible increased chest pain or risk of heart attack. It is rare, but when you first start taking Tekamlo or increase your dose, you
may have a heart attack or your angina may get worse. If that happens, call
your doctor right away or go directly to a hospital emergency room.

Renal impairment or failure. Aliskiren, one
of the medicines in Tekamlo, may cause renal disorder with symptoms such as
severely decreased urine output or decreased urine output (signs of renal
impairment or failure).

Less common side effects include rash, severe skin
reactions (signs may include severe blistering of the lips, eyes or mouth, rash
with fever and skin peeling) and liver disorder (signs may include nausea, loss
of appetite, dark colored urine or yellowing of skin and eyes).

Tell your doctor if you have any side effect that bothers
you or that does not go away.

These are not all of the possible side effects of
Tekamlo. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.

How do I store Tekamlo?

Store Tekamlo tablets at room temperature between 59°F to
86°F (15°C to 30°C).

Keep the original prescription bottle and store in a dry
place.

Protect Tekamlo from heat and moisture.

Keep Tekamlo and all medicines out of the reach of
children.

General information about Tekamlo

Medicines are sometimes prescribed for conditions not
listed in the patient information leaflet. Do not take Tekamlo for a condition
for which it was not prescribed. Do not give Tekamlo to other people, even if
they have the same condition or symptoms you have. It may harm them.

This leaflet summarizes the most important information
about Tekamlo. If you have questions about Tekamlo talk with your doctor. You
can ask your doctor or pharmacist for information that is written for
healthcare professionals.

For more information about Tekamlo, visit
www.Tekamlo.com, or call 1-888­NOW-NOVA (1-888-669-6682).

Blood pressure is the force of blood in your blood
vessels when your heart beats and when your heart rests. You have high blood
pressure when the force is too much.

High blood pressure makes the heart work harder to pump
blood through the body and causes damage to blood vessels. Tekamlo can help
your blood vessels relax so your blood pressure is lower. Medicines that lower
your blood pressure may lower your chance of having a stroke or heart attack.

Last reviewed on RxList: 11/15/2013
This monograph has been modified to include the generic and brand name in many instances.